Patients With Pancreatic Tumor: Use of an App to Monitor Progress in a Simple and Intuitive Way by Periodically Completing Targeted Questionnaires and Providing Educational and Informational Content.

NCT07532590 | Recruiting DMC

• 1 other identifier: 797CET
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 2

Brief Summary

Caring for people with pancreatic cancer requires good coordination between hospital care and care at home, with different healthcare professionals working closely together. Patients are also becoming more involved in managing their own care on a daily basis. However, this active involvement can be difficult if there is poor communication with healthcare teams, differences in skills or familiarity with digital tools, or systems that do not support patient participation. The PancreasPlus app was developed to support patients and caregivers by providing reliable information, self-monitoring tools, and a communication channel with healthcare professionals. The study aims to assess the feasibility, patient engagement, and perceived quality of routine use of the app. It is hypothesized that its use will improve engagement, perceived quality, reduce anxiety and unplanned hospital visits, without introducing technological or privacy risks. The app supports information and data collection but does not replace clinical decision-making. Objectives Primary objectives: Assess feasibility and patient engagement through questionnaire completion. Evaluate perceived service quality using the Client Satisfaction Questionnaire (CSQ-8). Secondary objectives: Monitor unplanned hospital visits and adherence to chemotherapy. Assess anxiety (HADS-A), nutritional status, and global quality of life (PROMIS Global). Evaluate usability and acceptability of the app (SUS, UTAUT2 short version). Endpoints Primary endpoints include questionnaire completion rates and perceived quality (CSQ-8 score). Secondary endpoints include unplanned hospital access, chemotherapy adherence, anxiety levels, nutritional status, quality of life, and app usability/acceptability. Methods This is a prospective, interventional, multicenter study with consecutive enrollment of eligible patients. Each participant will be followed for 3 months, with most activities conducted remotely via the app. At baseline (T0), patients receive study information, provide consent, undergo training, register in the app, and complete initial assessments (clinical, socio-demographic, PROMIS Global, HADS-A). At 12 weeks (W12), follow-up includes all outcome questionnaires and data on unplanned hospital visits. The app includes features such as a personal diary (symptoms, weight, BMI, appointments), interactive questionnaires with tailored feedback, and educational content on nutrition, prevention, emotional support, and patient rights. Population Inclusion criteria: adults (≥18 years) with pancreatic cancer, access to a smartphone/tablet (or caregiver support), ability to consent, and understanding of Italian. Exclusion criteria include severe cognitive impairment, inability to use the app or complete follow-up, or withdrawal of consent. Sample Size and Analysis A total of 185 patients will be enrolled (accounting for 10% dropout), based on an expected 70% engagement rate. Analyses will be conducted on both intention-to-observe and per-protocol populations. Engagement will be analyzed as questionnaire completion rates, while other outcomes will be analyzed using appropriate statistical models (e.g., logistic regression, ANCOVA, descriptive statistics). An interim analysis at 50% enrollment is planned to address potential low engagement.

Conditions

Ductal Adenocarcinoma of Pancreas; Pancreatectomy; Caregiver; Nutritional Evaluation; Post Surgery Patients; Pain Management

Keywords

App; Quality of life

Outcome Measures

Primary Outcomes (2)

• Feasibility and Engagement

  Feasibility and engagement will be assessed as a composite indicator of operational sustainability and active participation (co-production) in routine care. This will be operationalized as the proportion of enrolled participants who complete the scheduled questionnaires at Week 12.

  3 months

• Consumer-Perceived Quality of Care (CSQ-8 Score)

  Consumer-perceived quality of care will be assessed using the Client Satisfaction Questionnaire (CSQ-8; total score range: 8-32, with higher scores indicating greater satisfaction).

  3 months

Secondary Outcomes (7)

• App Usability (System Usability Scale - SUS)

  3 months

• Global Quality of Life (PROMIS Global Health - Global Physical Health [GPH] and Global Mental Health [GMH] scores)

  3 months (Baseline (T0) to Week 12)

• Anxiety (HADS-A Score)

  3 months (baseline (T0) to Week 12)

• Unscheduled Healthcare Utilization

  From baseline (T0) to 3 months (Week 12)

• Chemotherapy Adherence

  From baseline (T0) to 3 months (Week 12)

Study Arms (1)

PancreasPlus app

OTHER

Other: use of PancreasPlus app

Interventions

use of PancreasPlus app OTHER

If the participant chooses to take part, they will be asked to use the PancreasPlus app for approximately 3 months. The app is designed to support the care pathway by helping track symptoms, weight, and other health aspects. At the beginning, the participant will receive instructions to download the app and create an account. The participant will complete short questionnaires on physical and psychological wellbeing, including anxiety levels, quality of life, and satisfaction with the app. They will also access personalized content on symptom management, diet, treatments, and emotional support. If the app detects warning signs, it will suggest contacting the healthcare team but will not make clinical decisions. All medical decisions remain the responsibility of the treating physicians. Reminder calls may be made during the study.

PancreasPlus app

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18; diagnosis of pancreatic cancer (histological/cytological)
• Access to a smartphone or tablet and a data connection; basic digital literacy or a caregiver available,
• Ability to understand and provide informed consent; understanding of the Italian language.

You may not qualify if:

• Severe uncompensated cognitive impairment,
• Social or logistical circumstances that prevent follow-up or access to/use of the app,
• Refusal or withdrawal of consent.

Sponsors & Collaborators

• Casa di Cura Dott. Pederzoli: lead

Study Sites (2)

U.O. Chirurgia Generale 1, IRCCS San Matteo, Università degli Studi di Pavia

Pavia, Pavia, 27100, Italy

ACTIVE NOT RECRUITING

Ospedale P. Pederzoli Casa di Cura Privata S.p.A.

Peschiera del Garda, Verona, 37019, Italy

RECRUITING

MeSH Terms

Conditions

Agnosia; Alzheimer Disease

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dementia; Brain Diseases; Central Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 16, 2026
• Study Start: February 26, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)